CQV Engineer (Upstream Process Engineering)

Are you a CQV Engineer interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

Title: CQV Engineer (Upstream Process Engineering)

Location: Visp, Switzerland

Rate: Open

Openings: 1 Engineer

Contract/Perm: Contract (12-Months)

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities:

• Self-manage CQ development and execution activities with respect to the relevant systems.
• Function as a key member of the CQ Team, and provide guidance regarding Upstream SS Bioreactors + Harvest.
• Maintain control over the activities and schedule with respect to the relevant systems.
• Participate in sessions to define/agree work breakdown structure with respect to the relevant systems
• Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
• Coordination and communication with other resources for Upstream SS Bioreactors + Harvest-related matters.
• Adherence to ORCA project procedures/requirements with respect to Health/Safety/Environmental, Quality (including GDP/GMP), CQ (including MCP, MQP, DQ, IQ, OQ, Commissioning).
• Liaise closely with the relevant vendors/providers/contractors, project Automation representatives and Construction-phase representatives to ensure integration of activities and schedules with respect to the relevant systems.
• Actively participate in the development and delivery of deliverables with respect to the relevant systems.
• Report on key deliverable and dates and align with key milestones within the project's critical path.
• Report and aid in the resolution of project issues, including maintaining the non-conformance records.
• Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
• Prioritize and execute tasks in a fast-paced environment.

Requirements:

• Minimum Bachelor's degree in Life Sciences or Engineering
• Minimum of 6+ (Lead) / 4+ (Senior) / 2+ (Intermediate) years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
• Proven Upstream SS Bioreactors + Harvest system, CIP, and SIP knowledge. o Minimum 6+ (Lead) / 4+ (Senior) / 2+ (Intermediate) years of experience in commissioning / qualification / validation of Upstream SS Bioreactors + Harvest systems.
• Experience with DeltaV (Emerson).
• Fluent English language written and verbal communication skills.
• cGMP knowledge and knowledge of regulatory requirements.
• Able to work with minimum oversight fulfilling deliverables within target dates
• Fluent German is a distinct preference.
• Experience with Lonza Commissioning / Qualification Approach.
• Experience with COMOS/KNEAT platforms.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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